Active substance
Molindone
- US FDA 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MOLINDONE HYDROCHLORIDE | 5MG; 10MG; 25MG | tablet · oral | EPIC PHARMA LLC | Prescription | 20 Mar 2015 |
| MOBAN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | CHARTWELL RX | Discontinued | 18 Jan 1974 |
| MOBAN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | CHARTWELL RX | Discontinued | 18 Jan 1974 |
| MOBAN | 20MG/ML | concentrate · oral | ENDO PHARMS | Discontinued | 28 Dec 1979 |
Safety signals and safety-related labeling changes
- US FDA 22 Jan 2025 MOBAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.